Drug Cuts Amputation Risk in Diabetes

Fenofibrate & Amputation Risk: Study Results

Over the course of the study, 115 patients had amputations of the lower limbs related to their diabetes. The researchers also found:

Overall, the risk of first amputation was 36% lower for all patients given fenofibrate compared to those given placebo. Although 70 of those on placebo had amputation, 45 of those on the drug did.

The risk of minor amputation in patients who did not have large vessel disease was even lower, 47%, for those who took the drug compared to those who got the placebo.

Risks didn't differ significantly between groups for major amputations.

Height predicted risk of amputation. For every 4-inch increase in height, there was a 1.6-times boost in risk. (Best notes that this is not a new finding.)

Fenofibrate & Amputation: Take-Home Message

Best puts the study findings in perspective this way. "What we have to keep in mind is that amputation is not as common as heart attack [among those with type 2 diabetes]." Although the effect of the drug on amputation risk was significant, he says, "This doesn't mean everyone with diabetes should start taking fenofibrate to prevent amputation. The therapy should be targeted to those at high risk for amputation."

That includes those who have nerve damage in their feet from their diabetes, who have an ulcer on their foot, or who have had a previous amputation, Best says.

Fenofibrate & Amputation: Second Opinions

"It's an interesting study that may change some people's approach [to diabetes treatment]," says Richard Jackson, MD, senior physician at Joslin Diabetes Center and assistant professor of medicine at Harvard Medical School, Boston, who occasionally does prescribe the drug, typically to bring down high triglyceride levels.

But he adds a caveat. "The medication could be helpful, but it's only one study." More studies are needed, he says.

Another expert who reviewed the study findings for WebMD agrees. "We need to do a larger trial to understand its mechanism and confirm the findings," says Richard M. Bergenstal, MD, president-elect of the American Diabetes Association and executive director of the International Diabetes Center at Park Nicollet Health Services in Minneapolis.

Meanwhile, he says, the study results point to the importance of preventive care. The researchers found that the strongest predictors of a first amputation included a history of previous amputation or diabetic skin ulcers, nerve problem, or a history of peripheral vascular disease. "Anybody who has neuropathy and a history of amputation or ulcer, we need to follow them very closely because they are at higher risk."